Duns Number:482661753
Device Description: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 17mm x 30cm 190cm Contents: 1 Detachabl MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 17mm x 30cm 190cm Contents: 1 Detachable Coil System
Catalog Number
CSP18170030
Brand Name
MICRUSPHERE CERECYTE
Version/Model Number
CSP181700-30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082739
Product Code
HCG
Product Code Name
DEVICE, NEUROVASCULAR EMBOLIZATION
Public Device Record Key
826f17d7-c2e6-4b8b-b300-bafbf0902d95
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 972 |
2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
3 | A medical device with high risk that requires premarket approval | 20 |
U | Unclassified | 20 |